
Biomerieux Vitek, Inc.
Free shipping on orders over $99 · 30-day returns
VIDAS CREATINE KINASE MB ASSAY 30-421 is an FDA 510(k)-cleared medical device (K962549) manufactured by Biomerieux Vitek, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 1996. Regulation: 8.